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Denali Community Update March 2026

After 20 years of no new therapies, Denali’s AVALAYAH has been approved by the FDA! This blood brain barrier penetrating enzyme replacement therapy targets the neurological disease of Hunter syndrome. 

Today is a day to celebrate. Thank you to all the advocates, the families enrolled in the trial, the P.I.’s, the children desperately waiting for this therapy, Denali Therapeutics, and everyone that helped us get here. We also want to take a moment to remember everyone we have lost along the way while waiting for this day. You deserved access to treatment, too. 

Our work doesn’t end here as we now step into fighting for access to ensure every person living with Hunter syndrome has access to innovative therapies. 

Stay tuned for more details. Read the press release here:

Denali Community Update_March 2026.pdf

Have something you think we should share? Contact us at 313-31-ALIVE (313-312-5483) or press@projectalive.org.

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